Um Estudo Investigacional do BG-75202 Isoladamente e em Combinação com Outros Agentes Terapêuticos em Adultos com Tumores Sólidos Avançados
Um Estudo de Fase 1a/1b a Avaliar a Segurança, Tolerabilidade, Farmacocinética, Farmacodinâmica e Atividade Antitumoral Preliminar do BG-75202, Sozinho e em Combinação com Outros Agentes em Doentes com Tumores Sólidos Avançados
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Study Director
- Número de telefone: 877-828-5568
- E-mail: clinicaltrials@beonemed.com
Locais de estudo
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New South Wales
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Blacktown, New South Wales, Austrália, NSW 2148
- Recrutamento
- Blacktown Cancer and Haematology Centre
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Camperdown, New South Wales, Austrália, NSW 2050
- Recrutamento
- Chris Obrien Lifehouse
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South Australia
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Adelaide, South Australia, Austrália, SA 5000
- Recrutamento
- Cancer Research South Australia
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Victoria
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Heidelberg, Victoria, Austrália, VIC 3084
- Recrutamento
- Austin Health
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Melbourne, Victoria, Austrália, VIC 3000
- Recrutamento
- Peter Maccallum Cancer Centre
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Recrutamento
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 100021
- Recrutamento
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400030
- Recrutamento
- Chongqing University Cancer Hospital
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Fujian
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Xiamen, Fujian, China, 361003
- Recrutamento
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, China, 510555
- Recrutamento
- Sun Yat Sen University Cancer Center Huangpu Branch
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Recrutamento
- Harbin Medical University Cancer Hospital
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Hunan
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Changsha, Hunan, China, 410013
- Recrutamento
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210036
- Recrutamento
- Jiangsu Province Hospital Longjiang Branch
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201321
- Recrutamento
- Fudan University Shanghai Cancer Centerpudong
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Recrutamento
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Recrutamento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Barcelona, Espanha, 08035
- Recrutamento
- Hospital Universitario Vall Dhebron
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Barcelona, Espanha, 8023
- Recrutamento
- Next Oncology Barcelona
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Madrid, Espanha, 28041
- Recrutamento
- Hospital Universitario 12 de Octubre
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Madrid, Espanha, 28240
- Recrutamento
- Hospital Clinico San Carlos
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Málaga, Espanha, 29010
- Recrutamento
- Hospital Universitario Virgen de La Victoria
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-0004
- Recrutamento
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Recrutamento
- Yale Cancer Center
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Missouri
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St Louis, Missouri, Estados Unidos, 63110-1010
- Recrutamento
- Washington University in St Louis
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Texas
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Austin, Texas, Estados Unidos, 78758
- Recrutamento
- Next Oncology Austin
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Houston, Texas, Estados Unidos, 77030-4009
- Recrutamento
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98109-4433
- Recrutamento
- Fred Hutchinson Cancer Research Center
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Milan, Itália, 20141
- Recrutamento
- Istituto Europeo Di Oncologia
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Naples, Itália, 80131
- Recrutamento
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma, Itália, 00168
- Recrutamento
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano, Itália, 20089
- Recrutamento
- Istituto Clinico Humanitas
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Auckland, Nova Zelândia, 1023
- Recrutamento
- Auckland City Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies.
- Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload).
- Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.
- Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
- Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Prior exposure to KAT6A/B or KAT7 inhibitors/degraders.
- Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
Administered orally. |
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Experimental: Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. |
Administered orally. Administered by intramuscular injection. |
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Experimental: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist
Participants will receive BG-75202 in combination with an estrogen receptor antagonist. |
Administered orally. Administered by intramuscular injection. |
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Experimental: Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. |
Administered orally. Administered orally. Administered orally. |
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Experimental: Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor. |
Administered orally. Administered orally. Administered orally. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Part 1: Number of Participants with Adverse Events (AEs)
Prazo: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria. |
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
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Part 1: Recommended Dose for Expansion (RDFE)
Prazo: Estimated approximately 1 year
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The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data. |
Estimated approximately 1 year
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Part 2: Overall Response Rate (ORR)
Prazo: Up to approximately 2 years
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ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
Up to approximately 2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Partes 1 e 2: Concentração Plasmática Máxima Observada (Cmax) do BG-75202
Prazo: Até aproximadamente 4 meses
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Até aproximadamente 4 meses
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Partes 1 e 2: Concentração Plasmática Mínima Observada (Ctrough) do BG-75202
Prazo: Até aproximadamente 4 meses
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Até aproximadamente 4 meses
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Partes 1 e 2: Área Sob a Curva da Concentração Plasmática em Função do Tempo (AUC) do BG-75202
Prazo: Até aproximadamente 4 meses
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Até aproximadamente 4 meses
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Partes 1 e 2: Meia-Vida Terminal (t1/2) do BG-75202
Prazo: Até aproximadamente 4 meses
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Até aproximadamente 4 meses
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Part 1: ORR
Prazo: Up to approximately 1 year
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ORR is defined as the percentage of participants with partial response (PR) or complete response (CR), as assessed by the investigator using RECIST v1.1. |
Up to approximately 1 year
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Part 1: Duration of Response (DOR)
Prazo: Up to approximately 1 year
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DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first. |
Up to approximately 1 year
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Part 1: Time to Response (TTR)
Prazo: Up to approximately 1 year
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TTR is defined as the time from treatment initiation to the first determination of objective response. |
Up to approximately 1 year
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Part 2: DOR
Prazo: Up to approximately 2 years
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DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first. |
Up to approximately 2 years
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Part 2: TTR
Prazo: Up to approximately 2 years
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TTR is defined as the time from treatment initiation to the first determination of objective response. |
Up to approximately 2 years
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Part 2: Disease Control Rate (DCR)
Prazo: Up to approximately 2 years
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DCR is defined as the percentage of participants who achieve CR, PR, or stable disease as assessed by investigator's review. |
Up to approximately 2 years
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Part 2: Clinical Benefit Rate (CBR)
Prazo: Up to approximately 2 years
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CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks). |
Up to approximately 2 years
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Part 2: Progression-Free Survival (PFS)
Prazo: Up to approximately 2 years
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PFS is defined as the time from the date of the first dose of study treatment(s) to the date of the first documentation of disease progression assessed by investigator's review or death, whichever occurs first. |
Up to approximately 2 years
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Part 2: Number of Participants with Adverse Events (AEs)
Prazo: Up to approximately 2 years
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, and laboratory values. |
Up to approximately 2 years
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Part 2: Recommended Phase 2 Dose (RP2D)
Prazo: Up to approximately 2 years
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The RP2D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity. |
Up to approximately 2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Study Director, BeOne Medicines
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias da Mama
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Hormônios, substitutos hormonais e antagonistas hormonais
- Inibidores Enzimáticos
- Inibidores da síntese de esteróides
- Antagonistas hormonais
- Antagonistas de estrogênio
- Peptídeos
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Ações farmacológicas
- Ações e usos químicos
- Peptídeos e proteínas de sinalização intracelular
- Proteínas do ciclo celular
- Proteínas supressoras de tumor
- Proteínas da neoplasia
- Proteínas inibidoras de quinase dependentes de ciclina
- Inibidores de Aromatase
- Inibidor de quinase dependente de ciclina P16
- Antagonistas do Recetor de Estrogénio
Outros números de identificação do estudo
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 2025 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Prazo de Compartilhamento de IPD
See plan description
Critérios de acesso de compartilhamento IPD
See plan description
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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